Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 2, 2019
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Instrument stopped working due to a software lockup, and no patient results are produced.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Vital Scientific N.v. recalled V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic d… - a moderate-severity action.
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic d… was recalled by Vital Scientific N.v. in October 2, 2019. Reason: Instrument stopped working due to a software lockup, and no patient results are produced.. Check the official notice for the remedy. Verify recall #Z-2558-2019 with the FDA Devices before acting.
The recall
Vital Scientific N.v. issued this moderate-severity FDA Devices recall-Instrument stopped working due to a software lockup, and no patient results are produced..
- Moderate
- severity level
- 2 units
- affected scope
- Class II
- classification
- October 2, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2558-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2558-2019) was formally reported on October 2, 2019, with the manufacturer initiating the action on January 18, 2016. It is classified under Moderate severity (Class II), with a current status of Ongoing. Vital Scientific N.v. is listed as the recalling firm, operating out of Dieren. Federal records list the affected scope as 2.
The documented reason for this recall is: Instrument stopped working due to a software lockup, and no patient results are produced. Distribution data in the federal record shows the product reached: US in the state of New York.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2
Related Recalls
6
3 from same agency
Product description
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Reason for recall
Instrument stopped working due to a software lockup, and no patient results are produced.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2558-2019 |
| Date reported | October 2, 2019 |
| Date initiated | January 18, 2016 |
| Recalling firm | Vital Scientific N.v. |
| Firm location | Dieren |
| Affected scope | 2 |
| Distribution | US in the state of New York. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2558-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.. Recalled by Vital Scientific N.v.. Units affected: 2.
Why was this product recalled? ▼
Instrument stopped working due to a software lockup, and no patient results are produced.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2019. Severity: Moderate. Recall number: Z-2558-2019.
Where was the recalled product distributed? ▼
Distribution: US in the state of New York..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2558-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 2, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.